Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-09 @ 3:36 PM
Study NCT ID:
NCT00896961
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding in patients with high-grade soft tissue sarcoma of the trunk or extremity or squamous cell carcinoma of the oral cavity.
II. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients.
III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients.
IV. Determine the adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers in these patients.
OUTLINE:
Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration.
I. Determine biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding in patients with high-grade soft tissue sarcoma of the trunk or extremity or squamous cell carcinoma of the oral cavity.
II. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients.
III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients.
IV. Determine the adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers in these patients.
OUTLINE:
Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: